Conventionally, in the pharmaceutical industry, in order to guarantee safety and effectiveness of a medicine, post-marketing surveillance is conducted for a medicine being marketed. For the post-marketing surveillance, a contact person from a pharmaceutical manufacturer visits a doctor and makes requests for surveillance and trials of the medicine. The doctor fills out a predetermined survey form, which the contact person gave to the doctor, for each prescription case and signs on or affixes his seal to the predetermined survey form. Then, the predetermined survey form is provided to the pharmaceutical manufacturer from the doctor through a form collector. That is, in procedures for the post-marketing surveillance, generally, the doctor transcribes conditions of patients, for whom the doctor prescribed the medicine that the pharmaceutical manufacturer requested information about, from clinical charts to the survey forms. Then, the pharmaceutical manufacturer inputs information transcribed on the survey forms into a DB (database). The pharmaceutical manufacturer obtains statistics based on data inputted into the DB, analyzes the statistics and then reports a result of the post-marketing surveillance to the Ministry of Health and Welfare.
After that, the pharmaceutical manufacturer maintains and manages the survey forms signed or sealed by the doctor to ensure that the reported result is based on the survey forms from the doctor.
By conducting the above procedures, the safety and effectiveness of the medicine is guaranteed.
However, the above conventional procedures for the post-marketing surveillance have disadvantages as follows:
In order to report an accurate result to the Ministry of Health and Welfare, for example, when data are inputted from the survey forms to the DB in the pharmaceutical manufacturer, several persons separately input the same data to the DB. After that, the data inputted by each person in the DB is compared with each other and is reconfirmed to prevent mistakes of inputting data so as to improve accuracy of input data. In general, since the pharmaceutical manufacturer is under an obligation to survey more than a given number of cases, for example 3,000 cases, for one medicine, a large amount of time and labor power are required to verify consistency between data inputted by the several persons. However, it is still difficult to obtain accurate input data consistent with the data filled out by the doctor on the survey form.
Moreover, in a transcription from the clinical chart to the survey form by the doctor, for protection of a patient's privacy, it is required that the patient's name not be filled out on the survey form. Instead, an initial name is written on the survey form to specify that patient. After the consistency of the data inputted to the DB by the several persons of the pharmaceutical manufacturer is verified, a program is used to check for a logical conflict of the data. When the program finds the logical conflict in the survey form, the contact person of the pharmaceutical manufacturer visits and requests the doctor for the survey again by a request letter in which the contact person has made a comment for each logical conflict in the survey form to the doctor. Similarly, the above procedures are conducted again for the survey form provided from the doctor in response to the request. The procedures are repeated each time the survey is conducted until the survey form does not have any logical conflicts. When the credibility of the survey form is verified by repeating the survey, the data from the survey form is fixed. Therefore, the data becomes available to be analyzed by the pharmaceutical manufacturer and then the pharmaceutical manufacturer can report the analysis result to the Ministry of Health and Welfare.
In the conventional procedures for post-marketing surveillance, a considerable amount of labor and time of the doctor and the pharmaceutical manufacturer is consumed until the credibility of the data of the survey form is verified. Also, since the patient's name in the survey form to specify the patient is transcribed by the initial name by the doctor, the doctor has to find the clinical chart of that patient when the doctor is requested for the survey again. Thus, it is an inconvenience for the doctor. In other surveillance conducted by the pharmaceutical manufacturer, similar problems to the above procedures of post-marketing surveillance occur.